# DDGP versus SMILE in Newly Diagnosed Advanced Natural Killer/T-Cell Lymphoma: A Randomized Controlled, Multicenter, Open-label Study in China

Source: https://onco.cc/key-papers/paper-ddgp-vs-smile-nk-t-cell-lymphoma-clin-cancer-res-2016/  
OnCo record `paper-ddgp-vs-smile-nk-t-cell-lymphoma-clin-cancer-res-2016` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The interim report of the Chinese trial comparing two asparaginase regimens in advanced NK/T-cell lymphoma, on its first 42 patients.

## Summary

The interim report of the randomised trial registered as NCT01501149, in newly diagnosed stage III to IV NK/T-cell lymphoma with performance status 0 to 2, randomised to six cycles of DDGP or SMILE. Its primary endpoint was progression-free survival. The final analysis appeared in JAMA Oncology in 2022 and is the record to read for the result.

## Fields

- Kind: Key paper
- Last checked: 2026-11-03
- Also known as: DDGP versus SMILE, interim report; Li 2016
- Tags: lymphoma-evidence-entities
- Journal: Clinical Cancer Research
- Year: 2016
- DOI: 10.1158/1078-0432.CCR-16-0153
- Authors: Li X, Cui Y, Sun Z, et al.
- Findings: 42 patients enrolled, 21 in each arm.; One-year progression-free survival was 86 per cent with DDGP against 38 per cent with SMILE (p = 0.006), and two-year overall survival 74 against 45 per cent (p = 0.027).; Complete remission was 71 against 29 per cent (p = 0.005) and overall response 95 against 67 per cent (p = 0.018).; SMILE caused more serious leucopenia (p = 0.030) and more severe allergic reactions (p = 0.015); two patients on SMILE had grade 4 mucosal reactions.
- What it means: An interim look whose direction the final report confirmed with smaller differences. The early figures are larger than the final ones, which is the usual pattern of an interim analysis on a small sample.
- Caveats: Interim analysis of 42 patients; superseded by the final report of 80 treated patients in JAMA Oncology 2022.

## Sources

- Clinical Cancer Research 2016: https://doi.org/10.1158/1078-0432.CCR-16-0153
- PubMed: https://pubmed.ncbi.nlm.nih.gov/27060152/
- Europe PMC: https://europepmc.org/article/MED/27060152

## Connected records

- cancers: [Extranodal NK/T-cell lymphoma](https://onco.cc/cancers/extranodal-nk-t-cell-lymphoma/)
- drugs: [Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase)](https://onco.cc/drugs/asparaginase/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Dexamethasone](https://onco.cc/drugs/dexamethasone/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/)
- trials: [DDGP versus SMILE](https://onco.cc/trials/ddgp-vs-smile-enktl/)

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